Sampling and testing

Article 57 of the Council Regulation 726/2004 gives to the European Medicines Agency the responsibility to co-ordinate “the supervision, under practical conditions of use, of medicinal products which have been authorised within the Community”.

As part of this responsibility, the European Medicines Agency implements every year a sampling and testing programme, aimed at supervising the quality of the Centrally Authorised Products (CAPs) available on the European market. The objectives and description of the programme have been recently revised.

In carrying out the above duty, the European Medicines Agency is supported by other institutional partners (EDQM, OMCL network, national authorities and inspection services and rapporteurs), and by the marketing authorisation holders; each of these plays an important role in the success of the programmes.

Testing of CAPs can also be carried out by national authorities as part of the national supervision of the product concerned.

A trial programme, involving a small number of products was carried out in 1998. Regular annual programmes have been implemented since. Information on the numbers of the products tested each year is available.